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May 29, 2020

Shoreside Enterprises Inc. – 422722 – 05/26/2020

Delivery Method: VIA Electronic Mail Reference #: 20-HAFE4-WLCOL-07 Product: Drugs Recipient: Recipient Name Mr. Brian Moses Recipient Title President Shoreside Enterprises Inc. 6321 Newtown Cir.Apt B1Tampa, […]
May 29, 2020

FDA In Brief: FDA Takes Actions to Enhance Utility of the Orange Book

May 29, 2020 Media Inquiries   Jim McKinney  240-328-7305 The following quote is attributed to Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation […]
May 29, 2020

Anesthetic and Analgesic Drug Products Advisory Committee Charter

Committee’s Official Designation Anesthetic and Analgesic Drug Products Advisory Committee Authority The Anesthetic and Analgesic Drug Products Advisory Committee was established under 15 U.S.C. 1451 et […]
May 29, 2020

StayWell Copper Products – 607773 – 05/28/2020

Product: Drugs Recipient: Recipient Name Marcia Reece & Diana French StayWell Copper Products 2005 Lindenmeier RoadFort Collins, CO 80524United States [email protected] Date:               May 28, […]
May 29, 2020

Quadrant Sales & Marketing, Inc. – 607625 – 05/28/2020

Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States Date:               May 28, 2020 RE:                 Unapproved New Drug Products Related […]
May 29, 2020

Orange Book Questions and Answers Guidance for Industry

Submit Comments by 07/27/2020 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
May 28, 2020

Questions and Answers: NDMA impurities in metformin products

Updates on NDMA in metformin Important information about the NDMA impurity in metformin products The U.S. Food and Drug Administration has recommended recalls of certain metformin […]
May 28, 2020

Over-The-Counter Monograph User Fee Program (OMUFA)

On March 27, 2020, the President signed into law “the Coronavirus Aid, Relief, and Economic Security Act” (or the “CARES Act”). Division A of the CARES […]
May 28, 2020

Apotex Corp. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets 500mg Due to the Detection of N-nitrosodimethylamine (NDMA)

Summary Company Announcement Date: May 27, 2020 FDA Publish Date: May 28, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to detection of […]
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